SmartRockerBioreactor

Data File #807-DST-010-Rev1

Bioreactor Vessels

SmartRocker Bioreactor

Next generation rocking platform with integrated single-use sensors At Finesse, our goal is to enable customers to quickly and efficiently

manufacture innovative drugs and vaccines. The SmartRocker brings next

generation control and measurement to rocking bioreactor applications. A

SmartRocker is controlled by a G3Lab Universal SmartController and Finesse

TruBio software. This turn-key package provides a complete solution for

research, process development, or seed train production applications.

Optimize Cell Growth Designed for R&D and process scale-up, the SmartRocker allows

the user to configure the rocking motion from a smooth waveform

that minimizes shear forces for sensitive cell lines through four

intermediate steps to an aggressive motion that maximizes

oxygen transfer for robust cells with high oxygen demand.

Each Finesse SmartBag bioprocess container can be attached to a

SmartPuck incorporating three sensors (pH, dissolved oxygen, and

temperature). These process variables are utilized by the Finesse

SmartController to create the best possible cell culture environment.

Such closed loop feedback control allows the cell growth process to be

optimized for cell density, viability, productivity, and reproducibility.

Benefits Compatible with most

cell culture applications

Controlled environment

for faster cell growth

Short set-up time

SmartPuck sensor is USP

class VI compliant / ADCF

SmartPuck design minimizes

optical sensor drift

Plug-and-play with G3Lab Universal

Bioreactor Controllers

Powered by TruBio software

Standard service packages

cGMP compliant

Capabilities Rocking motion waveform control

Measurement and control

of critical process parameters:

pH

Dissolved Oxygen

Temperature

Optional load cell for weight control

Perfusion culture capable

Bioreactor Vessels

SmartBagsThe Finesse SmartBag single-use bioprocess container is currently

available in three (3) sizes: 10, 20, and 50 Liters. Each bag is delivered

with all relevant certificates and conforms to USP class VI specifications.

SmartBags are supplied in a single, standard configuration for each volume.

Please contact a Finesse representative if customization is required.

SmartBags are manufactured using five layer polyolefin-based

TepoFlex® film slip agent free from Meissner. This film provides superior

extractables and leachables profiles, water vapor and oxygen barriers and

complete fluid integrity. TepoFlex films are certified animal component

free and are manufactured in a class 7 cleanroom environment.

SmartBags are sterilized using gamma radiation (25-40 kGy) with

radiation indicators affixed to each SmartBag. Lot radiation information

can be provided upon request. Each lot is tested for bacterial

endotoxin; release requires endotoxin levels below 0.125 EU/ml.

SmartSensorsThe SmartBag is equipped with a SmartPuck sensor that incorporates

three single-use sensors for dissolved oxygen, pH, and temperature. The

SmartPuck leverages the technology behind TruFluor pH and TruFluor DO

in a compact assembly that is pre-calibrated using SmartChip technology

which provides accurate, drift-free, in-situ measurements. The combined

pH and DO optical SmartBag Reader uses advanced optical components

including large area photodiode that minimize photo-degradation of the active

pH and DO sensing elements. The SmartPuck also leverages the TruFluor

316L stainless steel thermal window for highly stable temperature readings.

The SmartPuck Sensor is welded into the single-use SmartBag to

eliminate the need for connectors and their associated complications

such as leakage and batch contamination. All wetted materials of

the SmartPuck are USP class VI compliant and animal-product

derived component free (ADCF) and, being identical to TruFluor

sensors, allow direct measurement comparisons and scale-up from

10L rocker bags to 2,000L stirred-tank single-use bioreactors.

SmartPuck Sensor

SmartBag Bioprocess Container

SmartRockerSPECIFICATIONS

Electrical Power 110 – 120 V~/220 – 240 V~, 50/60 Hz

Operating temperature (°C) 0 – 45°C (32 – 158°F)

Storage temperature (°C / °F) -40 to 70°C (-40 – 158°F)

Humidity <95%, non-condensing

Acoustic Noise Level < 70 dB A

Weight (Base+Tray) 38.5 kg (85 lbs)

Dimensions (h × w × d) 264 x 782 x 701 mm / 10.4 x 30.8 x 27.6 inches

Rocking Angle 2° – 12° per side

Rocking Rate 2 – 40 cycles per min

pH sensor range (pH units) 5.5 – 8.5

pH sensor relative accuracy ±0.05 pH over calibration range after a 2-point calibration having 0.3 – 0.8 pH units of separation

DO sensor range (% Sat) 0 – 250%

DO sensor limit of detection 0.03% O2

Accuracy @25°C: < ±1% at 20.95% O2

Temperature (°C) 10 – 45°C

Temperature accuracy (°C) ±0.15°C @ from 15 – 40°C

Precision (°C) ±0.1°C

Working Volume (L) 5, 10, 25

Toll free +1 800 598 9515 Finesse Solutions, Inc. Europe Asia-Pacific

Tel +1 408 570 9000 Global Headquarters Via Sogn Gieri 27a 3A Intl Business Park, #07-08

Fax +1 408 570 9009 3501 Leonard Court CH-7402 Bonaduz, ICON@IBP Tower A

www.finesse.com Santa Clara, CA 95054 Switzerland Singapore 609935

sales@finesse.com USA +41 81 641 2000 +65 8322 8128

Every effort has been made to ensure the accuracy of the information in this document. However, Finesse reserves the right to change its products without notice.

The following are Finesse Solutions, Inc. trademarks: TruView, TruBio, TruService, TruTorr, TruFluor, TruLogic, TruConnect, TruMigrations, TruCables, TruHousings, SmartGlass, SmartRocker,

TruDO, TrupH, SmartFactory, SmartChip, SmartSystems, SmartBag, SmartPuck, SmartReader, SmartBag Reader, SmartTray, SmartController, SmartSensor. © 2013-2014, Finesse Solutions, Inc.